NCT00223951已完成3 期
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
Vistakon Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 6
- 主要终点
- Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination
研究概览
简要总结
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better
排除标准
- •intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female < 18 years of age -
结局指标
主要结局
Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination
次要结局
- No additional endpoints
研究者
研究点 (6)
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